BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    ORBITAL RECONSTRUCTIVE IMPLANT II

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    WAKO CRP-UL, CRP-UL CALIBRATOR SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 19, 2021

    POLYFLUX 17L

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER·Product code KDI·January 14, 2020

    ZERO-P IMPLANT 7MM HEIGHT LORDOTIC/LARGE-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·April 29, 2013

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 10, 2011

    STERRAD NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 28, 2008

    LIFE SCOPE PT

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023

    LIFE SCOPE PT

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012